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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

rimegepant for Irritable Bowel Syndrome

Phase 2
Waitlist Available
Led By Michael Camilleri
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be 18-65 years of age.
Participants will have subjective pain ratings by a Likert scale of at least >3.0 for enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during days 26-28 of 4 week study
Awards & highlights

Study Summary

This trial aims to see if rimegepant can help reduce abdominal pain in people with irritable bowel syndrome (IBS) that is not caused by constipation.

Who is the study for?
Adults aged 18-65 with non-constipation IBS and chronic abdominal pain can join this trial. They must have a documented diagnosis, experience significant pain, and be able to consent. Excluded are those with severe depression, substance abuse issues, certain medical conditions like liver or kidney disease, recent changes in pain medication, or women who could be pregnant.Check my eligibility
What is being tested?
The study is testing if Rimegepant (a drug currently used for migraines) can reduce stomach pain in people with Irritable Bowel Syndrome that doesn't involve constipation. Participants will either receive Rimegepant or a placebo to compare the effectiveness.See study design
What are the potential side effects?
While not specified here, common side effects of Rimegepant may include nausea, dizziness and dry mouth based on its use for treating migraines. Each person's reaction to the medication can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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My pain level is more than 3 on a scale.
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I have IBS without constipation and chronic abdominal pain for over 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during days 26-28 of 4 week study
This trial's timeline: 3 weeks for screening, Varies for treatment, and during days 26-28 of 4 week study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
abdominal pain
Secondary outcome measures
colonic transit
rectal compliance
rectal sensation
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: rimegepantExperimental Treatment1 Intervention
Rimegepant 75mg oral dissolving tablet (ODT) Formulation and Dosing as FDA-approved for Migraine Prevention: 75 mg Every Other Day (EOD) for 4 weeks/30 days
Group II: placeboPlacebo Group1 Intervention
Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,916,733 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
700 Patients Enrolled for Irritable Bowel Syndrome
Mayo ClinicLead Sponsor
3,221 Previous Clinical Trials
3,767,928 Total Patients Enrolled
23 Trials studying Irritable Bowel Syndrome
1,137 Patients Enrolled for Irritable Bowel Syndrome
Michael CamilleriPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
30 Patients Enrolled for Irritable Bowel Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participation in this clinical study?

"Individuals between the ages of 18 and 65 who have been diagnosed with irritable bowel syndrome (IBS) are invited to participate in this clinical trial. The study aims to recruit approximately 24 eligible participants."

Answered by AI

Are participants currently being enrolled for this study?

"According to the information available on clinicaltrials.gov, this particular trial is not currently accepting new participants. The initial posting date was February 1st, 2024, and the most recent update occurred on January 14th, 2024. However, it's worth noting that there are currently a total of 118 other ongoing studies actively recruiting patients at this time."

Answered by AI

Has rimegepant received the official endorsement of the FDA for its use in medical treatments?

"Our team at Power assesses the safety of rimegepant to be 3, as this trial falls under Phase 4 and signifies that the treatment has already been approved."

Answered by AI

Is the age criteria for participation in this study inclusive of individuals aged 60 and above?

"To be considered eligible for this clinical trial, interested candidates must fall within the age range of 18 to 65. It is worth noting that there are a total of 15 ongoing trials specifically designed for individuals under the age of 18 and an additional 91 trials available exclusively for patients over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of Rimegepant and Placebo for Pain in IBS
Michael Camilleri, MD 2024. "Comparison of Rimegepant and Placebo for Pain in IBS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06221111.
All > Irritable Bowel Syndrome > Ibs
~16 spots leftby Mar 2025
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